This report is being filed after the subsequent review of the following literature article; this report is being filed after the subsequent review of the following literature article; (08/19/2009); use of vertical expandable prosthetic titanium rib for the treatment of congenital kyphosis in patients with thoracic myelomeningocele.¿ brazil; zuiani.This article reports complications that were reported in studies to evaluate clinical and radiographic postoperative results of congenital kyphosis correction in thoracic meningomyelocele pacientes vertical expandable prosthetic of using titanium for the rib (veptr).A retrospective study of 19 thoracic meningomyelocele and congenital kyphosis patients that were subjected to the veptr treatment between october 2005 and october 2008, with radiographic evaluation and immediate post and pre-operative clinical practice.Also, the duration of surgical procedure, the need for blood transfusion and postoperative complications were assessed.Technique related complications: of the 19 patient, three had complications related to the procedure after system installation.Specific complications were infection and rib fracture on one patient.Infections occurred after the stretching procedures.In one case of infection after stretching, it was necessary to remove one of the handles with their hooks as there was no response to surgical debridement and antibiotic therapy; another has a good response to treatment with antibiotics, hyperbaric oxygen therapy and would care.It was necessary to perform surgical debridement, with remission following.Both were treated with replacement of the implant at the time of surgery for stretching, debridement and antibiotic therapy, with good resolution of cases.In the event that rib fracture was presented, there was the repositioning of the assembly in a proximal to that rib fractured, with fracture healing and no new releases.This report is for 1 of 2 for (b)(4).This report is for an unknown veptr, unknown quantity, part and lot number.
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Device was used for treatment, not diagnosis.This report is for unknown veptr implant, unknown quantity, unknown item number, unknown lot number.(b)(4).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot and part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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